More Evidence That rtPA Therapy Has a Sustained Benefit
abstract & commentary
Source: Schmullin S, et al. One-year follow up in acute stroke patients treated with rtPA in clinical routine. Stroke 2000;31:1552-1554.
A recent report of long-term follow-up of the NINDS rtPA patients (The NINDS rtPA Stroke Study Group. N Engl J Med 1995;333:1581-1587) indicated that benefit was sustained at one year (Kwiatkowski TG, et al. N Engl J Med 1999;340:1781-1787) compared with the placebo group. Patients treated with rtPA within three hours after the onset of acute stroke symptoms were at least 32% more likely to have minimal or no disability at one-year follow-up. In the present study from Cologne, Schmulling and associates report the results of a 12-month follow-up of 150 consecutive patients with acute ischemic stroke treated with rtPA following a protocol comparable to the American Heart Association guidelines (Grond M, et al. Stroke 1998;29: 1544-1549; Adams HP, et al. Circulation 1996;94:1167-1174).
Baseline characteristics of the Cologne patients were comparable to those of the NINDS study except for a somewhat younger age (mean, 63 years vs 69 years in NINDS) and a less severe neurological deficit (median NIH stroke scale [Lyden P, et al. Stroke 1994;25:2220-2226] 11 vs 14 in NINDS).
Altogether, 132 patients had supratentorial and 18 had subtentioral stroke. Clinical outcome was assessed by physical examination and scored using the NIH Stroke Scale, the Rankin Scale (Van Swieten JC, et al. Stroke 1998;19:604-607), and the Barthel Index (Mahoney FI, Barthel DW. Md Med J 1965;14;61-65) at three months and 12 months by a structured telephone interview with the patient and/or caregivers.
Sixteen patients died during the first three months of observation. Parenchymal hemorrhage occurred in 12 patients (8%). In six patients, the cerebral hemorrhage was symptomatic (4%) and in two of these fatal. Eight others died of primary stroke-related causes and six others died of concomitant disease, especially cardiac.
At one year, 41% of patients showed minimal or no disability (Rankin, 0-1), 24% were moderately disabled (Rankin, 2-3), and 20% were severely disabled (Rankin, 4-5). Fifty-one percent were functionally independent (Barthel Index, 50-100). Functional outcomes of the Cologne group were comparable to those of the NINDS rt-PA Stroke Trial treated patients (see Table).
| Table | |||||
| Barthel Index of Functional Outcome at 12 months in Cologne Study and NINDS rtPA Stroke Trial Patients | |||||
| Barthel Index* | (95-100) | (55-90) | (0-50) | Death | |
| Cologne Study | 51% | 21% | 13% | 15% | |
| NINDS rt-PA treated patients | 50% | 13% | 13% | 24% | |
| NINDS placebo patients | 38% | 16% | 17% | 28% | |
| *Barthel Index: good, 95-100; moderate, 55-90; and poor functional outcome, 0-50 | |||||
Commentary
Even though the efficacy of the rtPA treatment for acute ischemic stroke has been demonstrated in several controlled trials, many neurologists remain reluctant to use it in clinical practice. The concern is that in routine use, thrombolytic treatment may have a higher complication rate and a lower effectiveness than when it is administered under ideal study conditions. The evidence from this study is that a sustained benefit at one year can be obtained from rtPA treatment in acute stroke patients under routine clinical conditions. If the guidelines for treatment and management are followed closely, the risks and benefits of thrombolytic treatment in everyday practice are similar to those obtained under the conditions of controlled trials. It is hoped that these observations will encourage the increased use of rtPA in appropriate clinical circumstances. —john j. caronna
At 12 months after treatment with rtPA, the percentage of patients who can be expected to have minimal or no disability (Barthel) is approximately:
a. 50%.
b. 40%.
c. 30%.
d. 25%.
e. 15%.
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